The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...

AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster ...

The FDA has approved a new treatment for patients with a common form of breast cancer that has spread to other parts of the ...

The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...

The FDA expanded the approval of trastuzumab deruxtecan for treatment of breast cancer.The new indication applies to use of ...

On January 17, 2025, the Food and Drug Administration (FDA) approved datopotamab deruxtecan-dlnk a Trop-2-directed antibody ...

A phase 3 clinical trial has shown that adding a targeted immunotherapy drug to chemotherapy dramatically improved – almost ...

The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast ...